FDA.report

Adler Instrument Company

Primary DI
00810123200535
Brand
Adler Instrument Company
Company
Adler, Inc.
Model
38-4984CC
Device description
Ejectr Kerr 40d up,8,4mm,ceram
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
HAERongeur, Manual

Product Code Classifications

CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810123200535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810123200535008101232005358101232005350810123200535

GMDN Terms

TermDefinition
Spinal rongeurA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. 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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