AccessGUDID - DEVICE: Acra Clip (00810607000200)

GUDID

Device Identifier (DI) Information

Brand Name: Acra Clip
Version or Model: 500-111
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 500-111
Company Name: ACRA-CUT INC

Primary DI Number: 00810607000200
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 612611459 *Terms of Use

Device Description: Serrated Edge,Medium Force,Adult Scalp Clip, One 15 Clip Cartridge

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
46950	Scalp clip forceps	A hand-held, manually-operated, surgical instrument used to manually apply and remove haemostatic scalp clips (reusable or single-use) from the scalp during or after a surgical intervention on the cranium/scalp. It is typically a scissors-like device with ring handles, and may or may not be self-retaining. The working end of the device will typically have dedicated grasping blades that are profiled/designed to accommodate a compatible scalp clip. The device is available in various sizes and is typically made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HBO	Clip, Scalp

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K944311	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: c553ef2f-c6ef-46ad-8041-bda8c717cfc5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: May 01, 2017

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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 9782632210
Email: info@acracut.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES