FDA.reportPublic FDA data

NA

Primary DI
04055207001325
Brand
NA
Company
Richard Wolf GmbH
Model
83071203
Catalog number
83071203
Device description
O-RING FOR TROCAR SLEEVE Ø 20MM reusable
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HETLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207001325PrimaryGS10
04055207059449Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207001325040552070013254055207001325
04055207059449040552070594494055207059449

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, reusableA 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 often 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 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. It is available in a variety of dimensions and/or designs. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter20Millimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags#

DUNS number
315304071
Device count
10
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04055207069226NA1006921006922026-03-12
04055207069257NA1006981006982026-03-12
04055207068243VERTEBRIS89250643892506432026-02-10
04055207069691NA8922090328922090322026-02-10
04055207069707NA8922090228922090222026-02-10
04055207069714NA8922090238922090232026-02-10
04055207069721NA8922090338922090332026-02-10
04055207069738NA89220922892209222026-02-10
04055207069745NA89220923892209232026-02-10
04055207069790NA8924084158924084152026-01-14
04055207069806NA8924084128924084122026-01-14
04055207069813NA8924084228924084222026-01-14
04055207069820NA8924084258924084252026-01-14
04055207069837NA8924089228924089222026-01-14
04055207069851NA8924089258924089252026-01-14
04055207036693POWER STICK M5/0899550000189955000012025-12-18
04055207000328NA20301052030.1052023-01-11
04055207067987VERTEBRIS8922012788922012782025-11-17
04055207067994VERTEBRIS8922020078922020072025-11-17
04055207068007VERTEBRIS8922020088922020082025-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06972304750414DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
16972304750381DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
16972304750398DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
16972304750428DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
16972304750435DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
04251303822769BLUEENDOTROKAMED GmbHHET2026-03-03
04251303824961BLUEENDOTROKAMED GmbHHET2026-02-27
04251303824978BLUEENDOTROKAMED GmbHHET2026-02-27
00817401029130EndoplusEndoplusHET2026-02-06
00817401029123EndoplusEndoplusHET2026-01-16
00817401029116EndoplusEndoplusHET2025-12-19
00198506086892ELMED INCORPORATEDELMED INCORPORATEDHET2025-11-25
G465FG16000Non-ICG 5mm Laparoscope (0 Deg)Smartsurgn Inc.HET2025-08-27
G465FG17000Non-ICG 5mm Laparoscope (30 Deg)Smartsurgn Inc.HET2025-08-27
00198506044229ELMED INCORPORATEDELMED INCORPORATEDHET2025-08-15
00198506084256ELMED INCORPORATEDELMED INCORPORATEDHET2025-07-24
04048223128121Cutting introducer cannula for Veress-Pajunk GmbH MedizintechnologieHET2025-06-17
04048223128145Cutting introducer cannula for Veress-Pajunk GmbH MedizintechnologieHET2025-06-17
EAMIICT50100i-Cut Power SupplyAMI Agency for Medical Innovations GmbHHET2025-05-05
EAMIICT50110i-CutAMI Agency for Medical Innovations GmbHHET2025-05-05
EAMIICT50500i-Cut Power Supply Type AAMI Agency for Medical Innovations GmbHHET2025-05-05
00198506082542ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-30
00198506026096ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-15
00198506026119ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-15
00198506027215ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-15
00198506027222ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-15
00817401029109EndoplusEndoplusHET2025-04-10
00198506081330ELMED INCORPORATEDELMED INCORPORATEDHET2025-03-17
00817401029093EndoplusEndoplusHET2025-03-14