FDA.reportPublic FDA data

Cervos Lipo Pro Double Pack

Primary DI
10858690006836
Brand
Cervos Lipo Pro Double Pack
Company
RANFAC CORP.
Model
CER-LP-40
Catalog number
CER-LP-40
Device description
CER-LP-40 FAT GRAFTING PROCEDURE PACK PN: 76119-01M
Published
2022-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUUSystem, Suction, Lipoplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUUSystem, Suction, LipoplastyGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150156000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150156000Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment VesselRanfac, Corp.2015-10-19MUU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858690006836PackageGS112In Commercial Distribution
00858690006839PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085869000683610858690006836
00858690006839008586900068398586900068390858690006839

GMDN Terms#

Term, Definition table
TermDefinition
Autologous adipose tissue collection/injection setA collection of sterile devices intended for both harvesting fat tissue from a patient and subsequently injecting the fat tissue into the patient from which it was taken (autologous) for aesthetic body contouring during reconstructive/cosmetic surgery. It typically consists of various needles/cannulae, syringes, and accessories (e.g., caps, connectors). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume40Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5085884400info@ranfac.com

Regulatory Flags#

DUNS number
121622872
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850023741226Cervos Flex Bone Marrow Aspiration Needle8 Gauge x 9.1cmCER-FLEX2021-07-16
00850023741462CER-LA11 GA X 16.5 CMCER-LA2021-11-10
00850023741479CER-FLEX8 GA X 9.1 CMCER-FLEX2021-11-10
00858690006808Cervos Lipo Pro Double PackCER-LP-40CER-LP-402022-09-19
00850023741561CERVOS PLATELET SEPARATOR 80 KITCER-PRP-80CER-PRP-802026-03-30
00850075308088CER-PRP-160 STERILITY PACKCER-PRP-160-SCER-PRP-160-S2026-03-30
00850075308101CER-PRP-160 KitCER-PRP-160CER-PRP-1602026-03-30
00850075308163CER-PRP-40 KIT F/G, STERILECER-PRP-40CER-PRP-402026-03-30
M9797405001M0NDL, RBN-114, STERILE, F/G"11 GAUGE x 4"""RBN-1142017-05-08
M9797405003M0NDL, RBN-133, STERILE, F/G"13 GAUGE x 3"""RBN-1332017-05-08
M9797405005M0NDL, RBN-132"13 GAUGE x 2"""RBN-1322017-05-08
M9797405006M0NDL, RBN-84, STERILE, F/G"8 GAUGE x 4"""RBN-842017-05-08
M9797405001M9NDL, RBN-114, STERILE, F/G11 GAUGE x 4"RBN-1142017-05-08
M9797405003M9NDL, RBN-133, STERILE, F/G13 GAUGE x 3"RBN-1332017-05-08
M9797405005M9NDL, RBN-13213 GAUGE x 2"RBN-1322017-05-08
00850075308095CER-PRP-SINGLE-ACER-PRP-SINGLE-ACER-PRP-SINGLE-A2025-10-08
00850075308019HYDRACELL-ORTHO-511 Gauge x 6.1CM 5ccHYDRA-ORTHO-52025-09-25
00850075308033HYDRACELL-ORTHO-1011 Gauge x 6.1CM 10ccHYDRA-ORTHO-102025-09-25
00850075308040HYDRACELL-EXT-511 Gauge x 6.3 CM 5ccHYDRA-EXT-52025-09-25
00850075308064HYDRACELL-EXT-1011 Gauge x 6.3 CM 10ccHYDRA-EXT-102025-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130455843Medco ManufacturingMedco Manufacturing LLCMUU2026-03-31
04260632793640TLA Tubing Liposat Pro plusMöller Medical GmbHMUU2026-02-27
04260632794043TLA Tubing Liposat Pro plusMöller Medical GmbHMUU2026-02-27
00850000712478Autoclavable Suction Jar with Hose Barb extension - 250mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712485Autoclavable Suction Jar with Hose Barb extension - 500mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712492Autoclavable Suction Jar with Hose Barb extension - 1000mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712508Autoclavable Suction Jar with Hose Barb extension - 2000mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712515Autoclavable Suction Jar with Hose Barb extension - 3000mLMillennium Medical Technologies, Inc.MUU2026-01-29
00810130455812Medco ManufacturingMedco Manufacturing LLCMUU2026-01-15
00810130455829Medco ManufacturingMedco Manufacturing LLCMUU2026-01-15
00810130455485Medco ManufacturingMedco Manufacturing LLCMUU2025-09-11
00810130455195Medco ManufacturingMedco Manufacturing LLCMUU2025-06-26
00810130455201Medco ManufacturingMedco Manufacturing LLCMUU2025-06-26
08800052308909FPU(Fat Processing Unit)Medikan Co., Ltd.MUU2025-05-20
08800052308886FPU(Fat Processing Unit)Medikan Co., Ltd.MUU2025-05-20
08800052316904FPU(Fat Processing Unit)Medikan Co., Ltd.MUU2025-05-20
00810130454839Medco ManufacturingMedco Manufacturing LLCMUU2025-02-27
00385640084987SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640084994SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640085007SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640085014SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640085021SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
07612367000109Silicone tubing ID 6.5mm, 180cm, 1 coupling pieceMedela AGMUU2024-05-31
07612367003551Quiver 280mmMedela AGMUU2024-05-31
07612367003568Quiver 480mmMedela AGMUU2024-05-31
07612367003698Overflow protection deviceMedela AGMUU2024-05-31
07612367003735Reusable serial connectorMedela AGMUU2024-05-31
07612367003742Safety Set for railholderMedela AGMUU2024-05-31
07612367003896Tubing holder left sideMedela AGMUU2024-05-31
07612367003902Tubing holder right sideMedela AGMUU2024-05-31