FDA.report

Adler Instrument Company

Primary DI
00810123200085
Brand
Adler Instrument Company
Company
Adler, Inc.
Model
60-5160
Device description
BOZEMAN FCPS 10-1/4 CVD
Published
2023-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HCZForceps, Surgical, Gynecological

Product Code Classifications

CodeDeviceSpecialtyClass
HCZForceps, Surgical, GynecologicalObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810123200085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810123200085008101232000858101232000850810123200085

GMDN Terms

TermDefinition
Uterine tenaculumA hand-held manual surgical instrument with hooks at the distal end used for grasping and/or manipulating uterine tissue during a surgical intervention or examination of the uterus and associated structures (e.g., cervix). It typically has a scissors-like, self-retaining design with ring handles and is made of high-grade stainless steel. It is available in various sizes. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
8772416747orders@theadlerinstruments.com

Regulatory Flags

DUNS number
830141235
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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