AccessGUDID - DEVICE: AC DEVICE (05060433600166)

GUDID

Device Identifier (DI) Information

Brand Name: AC DEVICE
Version or Model: LDCW09
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LDCW09
Company Name: Lockdown Medical Ltd

Primary DI Number: 05060433600166
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 211167885 *Terms of Use

Device Description: 9mm Washer

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:	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?
47030	Ligament graft, synthetic polymer	An implantable, non-bioabsorbable device made of synthetic polymer materials (e.g., polyester) intended to be used to replace a missing or damaged ligament to restore natural function. Some types may in addition include a metal anchoring component (e.g., staple, screw) for fixation onto bone; disposable devices associated with implantation may be included. Also referred to as a ligament prosthesis, it is commonly used for ligament reconstruction in the knee [e.g., patellofemoral ligament, anterior cruciate ligament (ACL)] or shoulder (e.g., glenohumeral ligament) joints.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HTN	Washer, Bolt Nut

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091207	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 0.9 Centimeter

Device Record Status

Public Device Record Key: 77e1c29e-3625-4661-85fe-34e8fcd72c0f
Public Version Date: November 23, 2021
Public Version Number: 4
DI Record Publish Date: October 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: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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

FDA TOOLS & RESOURCES