AccessGUDID - DEVICE: Anjon Bremer Halo System (00810592030206)

GUDID

Device Identifier (DI) Information

Brand Name: Anjon Bremer Halo System
Version or Model: Crown, Large, 23-26 in (58-66cm)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AHT036H
Company Name: ANJON HOLDINGS LLC

Primary DI Number: 00810592030206
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080902221 *Terms of Use

Device Description: Anjon Bremer Halo System Crown, Large 23-26 in (58-66cm)

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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):	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?
32854	Orthopaedic bone pin, non-bioabsorbable	A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a K-Wire, it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JEC	Component, Traction, Invasive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171863	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: b04557a7-c811-4ff2-9d50-51446aa97213
Public Version Date: September 18, 2023
Public Version Number: 3
DI Record Publish Date: April 20, 2018