AccessGUDID - DEVICE: ACE (00614950012886)

GUDID

Device Identifier (DI) Information

Brand Name: ACE
Version or Model: 8372161
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8372161
Company Name: ACE SURGICAL SUPPLY CO., INC.

Primary DI Number: 00614950012886
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042763706 *Terms of Use

Device Description: ELBOW IMMOBILIZER CHILD 7"

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?
10184	Armboard, reusable	A device designed to stabilize a patient's arm during an intervention or procedure typically to maintain the patency of an intravenous (IV) needle or an intravascular catheter. It is typically an elongated, flat surface of expanded polystyrene, wood, or artificial fibre board that is covered with a durable plastic or coating that can be easily cleaned. It may have a metal attachment so that it can be affixed to, e.g., an operating/examination table, a blood donor couch, or a chair, or it may be placed on a flat surface (e.g., on top of an operating/examination table). This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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: No special storage conditions required

Clinically Relevant Size

[?]

Size Type Text
Length: 7 Inch

Device Record Status

Public Device Record Key: 747ea85b-41e5-476c-ab95-5e03e51db8a4
Public Version Date: October 21, 2019
Public Version Number: 1
DI Record Publish Date: October 13, 2019

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

Customer Contact

[?]

Phone: +1(508)588-3100 ext: 214
Email: ritaknight@acesurgical.com

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