FDA.reportPublic FDA data

NA

Primary DI
03700393300233
Brand
NA
Company
PETERS SURGICAL
Model
12060
Catalog number
12060
Device description
Single use, sharp trocar for laparoscopic surgery
Published
2016-09-12
Public version status
Update
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
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071976000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071976000VECTEC DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIESVectec2007-09-06GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700393300233PackageGS125In Commercial Distribution
03700393300240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700393300233037003933002333700393300233
03700393300240037003933002403700393300240

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, single-useA single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments; it may additionally be intended for thoracoscopy whereby the valve may not be required. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 508-747-6033e.knupp@peters-surgical.com

Regulatory Flags#

DUNS number
265741780
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661522011782CARDIOXYL ®73S15B2020-01-04
03661522011805CARDIOXYL ®73P30A2020-01-04
03661522011812CARDIOXYL ®73P30B2020-01-04
03661522011829CARDIOXYL ®73P30D2020-01-04
03661522011836CARDIOXYL ®73P30E2020-01-04
03661522011843CARDIOXYL ®73P30F2020-01-04
03661522011850CARDIOXYL ®73P30G2020-01-04
03661522011867CARDIOXYL ®73P30I2020-01-04
03661522011874CARDIOXYL ®73P30J2020-01-04
03661522011881CARDIOXYL ®73P30K2020-01-04
03661522011898CARDIOXYL ®73P30L2020-01-04
03661522011904CARDIOXYL ®73P30O2020-01-04
03661522011911CARDIOXYL ®73P30P2020-01-04
03661522011928CARDIOXYL ®73P30Q2020-01-04
03661522011935CARDIOXYL ®73P30R2020-01-04
03661522011942CARDIOXYL ®73P30S2020-01-04
03661522011959CARDIOXYL ®73P30T2020-01-04
03661522011966CARDIOXYL ®73S15C2020-01-04
03661522011973CARDIOXYL ®73S20A2020-01-04
03661522011980CARDIOXYL ®73S20B2020-01-04

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Primary DI, Brand, Company table
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00190776435752MillenniumAvalign Technologies, Inc.GEI2026-10-21
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B108499AP1MRA1MUS00Large applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDGEI2026-10-20
00190776435288MillenniumAvalign Technologies, Inc.GEI2026-10-19
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B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
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B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
00860016247000Super PencilRF KINETICS LLCGEI2026-10-17
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00860016247024Super PencilRF KINETICS LLCGEI2026-10-17
00860016247031Super PencilRF KINETICS LLCGEI2026-10-17
00841019124017KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124024KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124048KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124079KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124086KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124093KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124109KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16