AccessGUDID - DEVICE: POLARCUP (07611996098532)

GUDID

Device Identifier (DI) Information

Brand Name: POLARCUP
Version or Model: 75017136
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 75017136
Company Name: Smith & Nephew, Inc.

Primary DI Number: 07611996098532
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045483575 *Terms of Use

Device Description: POLARCUP FLEXIBLE TWIST DRILL DIA6.0

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?
43962	Drilling power tool attachment, basic	A device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a drilling function when an appropriate drill bit is inserted. It may include integral design features, e.g., have an angled head, be cannulated, have an attached Jacobs chuck, or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
LWJ	Prosthesis, hip, semi-constrained, metal/polymer, uncemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123598	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: df2a2238-f29a-49cf-b7d9-17f595b2fc92
Public Version Date: September 07, 2023
Public Version Number: 4
DI Record Publish Date: November 25, 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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