AccessGUDID - DEVICE: BIO-RAY A-1 Anchor Screw System (04719879409727)

GUDID

Device Identifier (DI) Information

Brand Name: BIO-RAY A-1 Anchor Screw System
Version or Model: A-1P-401510
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MICROWARE PRECISION CO., LTD.

Primary DI Number: 04719879409727
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 658650833 *Terms of Use

Device Description: A-1P Anchorage Screw, Ø1.5 x L10mm, w/o Hole

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):	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?
46536	Orthodontic anchoring screw	A small, metallic, implantable rod with a spiral thread and slotted/formed head that is inserted into the bone of the jaw to serve as a temporary anchor for an orthodontic device (e.g., a spring or plate). It is available in various sizes and lengths, and may have a self-drilling/self-tapping thread for easy insertion and removal after desired alignment of the teeth. It is used in a variety of orthodontic treatment situations, especially when normal anatomy has been compromised (e.g., due to periodontal disease or agenesis, displacement of teeth in the same direction, asymmetrical anatomy). This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OAT	Implant, Endosseous, Orthodontic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182929	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: c0e01c30-b5e5-47fa-8748-05f15c4339fc
Public Version Date: May 20, 2026
Public Version Number: 1
DI Record Publish Date: May 12, 2026