FDA.report

Ambler Surgical

Primary DI
00190660147013
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Ferris-Smith laminectomy kerrison rongeur
Catalog number
75-440
Device description
Ferris-Smith laminectomy kerrison rongeur, 10 1/2'', working length 210mm, angled 90 degrees down, 4.0mm x 4.0mm bite, finger grip handle
Published
2021-01-07
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
KBBRONGEUR, NASAL

Product Code Classifications

CodeDeviceSpecialtyClass
KBBRongeur, NasalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190660147013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660147013001906601470131906601470130190660147013

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
+1(888)407-0006sales@amblersurgical.com

Regulatory Flags

DUNS number
015272206
Device count
1
DM exempt
false
Premarket exempt
true
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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