FDA.report

GEN2

Primary DI
00840343712433
Brand
GEN2
Company
SURGIX MEDICAL LLC
Model
G2N77866
Catalog number
G2N77866
Device description
CASPAR IVD, TEETH, 5X14MM, UP 6.25"
Published
2022-10-24
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
G277G2N778660PreviousHIBCC0
00840343712433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343712433008403437124338403437124330840343712433

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length6.25Inch

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
888-247-0477customerservice@surgixmedical.com

Regulatory Flags

DUNS number
080402644
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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