AccessGUDID - DEVICE: Berghaus/Schrom (M6332815060)

GUDID

Device Identifier (DI) Information

Brand Name: Berghaus/Schrom
Version or Model: 28-1506
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 28-1506
Company Name: JEDMED INSTRUMENT COMPANY

Primary DI Number: M6332815060
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092987189 *Terms of Use

Device Description: Lid-Chain Berghaus/Schrom 0.6GM

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?
18074	Eyelid weight, implantable	An ophthalmic device that is implanted subcutaneously within the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle (musculus orbicularis oculi) function. This device is used for the treatment of lagophthalmos, a condition that frequently results from facial paralysis caused by Bell's palsy, trauma, a stroke, or as an indirect consequence of the surgical removal of certain types of tumour in close proximity to the facial nerve. This device uses gravity to gently close the upper eyelid when blinking or when the eyelid muscle is relaxed, and is made of a heavy material [e.g., gold (Au), platinum (Pt)].	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MML	Weights, Eyelid, External

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K021750	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
Weight: 0.6 Gram

Device Record Status

Public Device Record Key: adc0ad52-281e-44b9-acd4-187ea4a90b9b
Public Version Date: April 22, 2019
Public Version Number: 3
DI Record Publish Date: December 14, 2016

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: 314-845-3770
Email: info@jedmed.com

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