FDA.report

NA

Primary DI
23596010655893
Brand
NA
Company
Smith & Nephew, Inc.
Model
72203127
Catalog number
72203127
Device description
HIGH VISIBILITY SHEATH 5.5 MM ABRADER BURR
Published
2015-08-29
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

Related Records

Product Codes

CodeName
HABSAW, POWERED, AND ACCESSORIES

Product Code Classifications

CodeDeviceSpecialtyClass
HABSaw, Powered, And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
23596010655893PackageGS13In Commercial Distribution
03596010655899PrimaryGS10

GMDN Terms

TermDefinition
Arthroscopic shaver system blade, single-useA sterile, powered, rotational, cutting device designed for use in an arthroscopic shaver system handpiece for soft and bone tissue resection during arthroscopic surgery on a joint, e.g., a knee, shoulder, or ankle. It is locked into a handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector. The inner and outer tubes are typically made of high-grade stainless steel; the hub and connector may be made of stainless steel or a polymer [e.g., polyphenylsulfone (PPSU)]. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags

DUNS number
109903521
Device count
1
DM exempt
false
Premarket exempt
true
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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00885556919712Real IntelligenceROB30001ROB300012026-03-10
00885556919729Real IntelligenceROB30002ROB300022026-03-10
00885556919743Real IntelligenceROB30003ROB300032026-03-10
00885556919750Real IntelligenceROB30004ROB300042026-03-10
00885556919767Real IntelligenceROB30005ROB300052026-03-10
00885556919774Real IntelligenceROB30006ROB300062026-03-10
00885556924198Real IntelligenceROB30026ROB300262026-03-10
00885556924204Real IntelligenceROB30021ROB300212026-03-10
00885556924211Real IntelligenceROB30027ROB300272026-03-10
00885556924228Real IntelligenceROB30022ROB300222026-03-10
00885556924235Real IntelligenceROB30023ROB300232026-03-10
00885556924242Real IntelligenceROB30024ROB300242026-03-10
00885556924266Real IntelligenceROB30028ROB300282026-03-10
00885556924273Real IntelligenceROB30020ROB300202026-03-10
00885556924297Real IntelligenceROB30880ROB308802026-03-10
20885556924307NAROB30031ROB300312026-03-10
00885556787786NA74034136740341362026-02-20
00885556884027NA74038834740388342026-02-20
00885556884034NA74038835740388352026-02-20
00885556884140NA74038846740388462026-02-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00889795128737Baby Gorilla/Gorilla Plating SystemParagon 28, Inc.HAB2026-01-29
00889795110879APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HAB2026-01-28
00889795118400APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HAB2026-01-28
00889795118417APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HAB2026-01-28
00889795118424APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HAB2026-01-28
00889795118431APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HAB2026-01-28
00889795118448APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HAB2026-01-28
00889795118455APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HAB2026-01-28
00889795128720Baby Gorilla/Gorilla Plating SystemParagon 28, Inc.HAB2026-01-28
10653405990734Hall® Titan™Conmed CorporationHAB2025-12-29
10653405990741Hall® Titan™Conmed CorporationHAB2025-12-29
00885556887165PLATINUMSmith & Nephew, Inc.HAB2024-05-17
00840124510326LapiLockFUSION ORTHOPEDICS, LLCHAB2023-11-01
00840124510333LapiLockFUSION ORTHOPEDICS, LLCHAB2023-11-01
00889795131041FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131058FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131065FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131072FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131089FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131096FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131102FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131119FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131126FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131133FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131140FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131157FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131164FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131171FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131188FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131195FJ2000 SystemPARAGON 28, INC.HAB2023-10-25