FDA.reportPublic FDA data

INSUFFLATION NEEDLE,15CM

Primary DI
20858690006994
Brand
INSUFFLATION NEEDLE,15CM
Company
RANFAC CORP.
Model
14 Gauge x 15 cm
Catalog number
IN-15
Device description
INSUFFLATION NEEDLE,15CM,RANFAC IN-15 PN 68017-02M
Published
2018-03-02
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
FHOPneumoperitoneum Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHOPneumoperitoneum NeedleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K930474000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930474000NEEDLE, PNEUMOPERITONEUM, SPRING LOADEDRanfac, Corp.1993-07-23FHO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858690006997PackageGS110In Commercial Distribution
20858690006994PackageGS116In Commercial Distribution
00858690006990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085869000699710858690006997
2085869000699420858690006994
00858690006990008586900069908586900069900858690006990

GMDN Terms#

Term, Definition table
TermDefinition
Spring-loaded pneumoperitoneum needle, single-useA slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. It is equipped with a spring-loaded, round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage from the sharp point. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Centimeter

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
false
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

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M9797405001M0NDL, RBN-114, STERILE, F/G"11 GAUGE x 4"""RBN-1142017-05-08
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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
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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

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Primary DI, Brand, Company table
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