FDA.report

PLATINUM

Primary DI
00885556887165
Company
Smith & Nephew, Inc.
Model
72205734
Catalog number
72205734
Device description
PLATINUM MDU BF
Published
2024-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Regulatory Flags

DUNS number
045483575
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00885556887165PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00885556887165PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
HABSaw, Powered, And Accessories1General, Plastic Surgery878.4820NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Arthroscopic shaver system handpiece, pneumaticA handle with attached cutting blade that is a component of a pneumatically-powered shaver system designed for soft and bone tissue resection during arthroscopic surgery on a joint, e.g., a knee, shoulder, or ankle. It is typically connected to and regulated by a dedicated control unit. It may facilitate additional functions of the system (e.g., irrigation/suction) and is used in combination with appropriate endoscopic devices. This is a reusable device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

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00885556787786NA74034136740341362026-02-20
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00885556884140NA74038846740388462026-02-20

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