AccessGUDID - DEVICE: BIRMINGHAM HIP (03596010533289)

GUDID

Device Identifier (DI) Information

Brand Name: BIRMINGHAM HIP
Version or Model: 90127556
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 90127556
Company Name: Smith & Nephew, Inc.

Primary DI Number: 03596010533289
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045483575 *Terms of Use

Device Description: BIRMINGHAM HIP SLIDE HAMMER EXTRACTOR

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44597	Orthopaedic cement extractor, manual	A hand-held manual surgical instrument designed to extract orthopaedic (bone) cement from a site of previous application during an orthopaedic surgical procedure to replace a previously cemented prosthesis. This GMDN code may include slide hammers, chisels, or other manually-operated devices which are intended to be used to break up the bone cement for removal. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NXT	Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P040033	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a708c92a-e329-49f1-b4b5-b32dea197326
Public Version Date: September 07, 2023
Public Version Number: 5
DI Record Publish Date: April 30, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)238-7538
Email: GUDID@SMITH-NEPHEW.COM

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