AccessGUDID - DEVICE: ELMED (00842180136885)

GUDID

Device Identifier (DI) Information

Brand Name: ELMED
Version or Model: 52505-98
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 52505-98
Company Name: ELMED INCORPORATED

Primary DI Number: 00842180136885
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 049290364 *Terms of Use

Device Description: 5 MM DIA., 33 CM, MYOMA DRILL

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?
35874	Myoma screw, reusable	A hand-held manual surgical instrument designed to engage, stabilize, and manipulate a myoma (i.e., a uterine fibroid) and other gynaecological tissues during their surgical removal. It is typically a one-piece instrument designed as a corkscrew having a pointed helicoidal stainless steel screw at the distal end, with a long slender shaft and a handle at the proximal end; it may be inserted through another device (e.g., laparoscope, hysteroscope, trocar) or be used during open surgery. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181173	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: 38b306c1-9f88-48aa-8b53-bf5ce319b133
Public Version Date: May 08, 2020
Public Version Number: 1
DI Record Publish Date: April 30, 2020

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 224-353-6446
Email: medical@elmed.com

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