AccessGUDID - DEVICE: NA (07332747175776)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 37881
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 37881
Company Name: Nobel Biocare AB

Primary DI Number: 07332747175776
Issuing Agency: GS1
Commercial Distribution End Date: October 24, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 353939929 *Terms of Use

Device Description: Abutment Retrieval Instr Ti CC RP/WP

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?
62358	Screw extractor, reusable	A hand-held manual surgical tool designed to remove implanted screws that have a damaged screw recess by self-tapping into the defective recess/head and providing sufficient grip to rotate and remove the screw in the normal way. It typically has a conical tip. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDP	Accessories, implant, dental, endosseous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Special Storage Condition, Specify: Keep away from sunlight. Keep dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bfff4aaa-49c3-47d3-a928-3dc7a1e9dc94
Public Version Date: October 25, 2023
Public Version Number: 3
DI Record Publish Date: July 22, 2022

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: Yes
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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)322-5001
Email: us.customerservice@nobelbiocare.com

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