FDA.report

Integra® Jarit®

Primary DI
M2742201751
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
220-175
Catalog number
220175
Device description
Hennig Cast Spreader, 11"
Published
2018-02-16
Public version status
Update
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
LGGINSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL

Product Code Classifications

CodeDeviceSpecialtyClass
LGGInstrument, Cast Application/Removal, ManualOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780381747PrimaryGS10
M2742201751SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178038174710381780381747

GMDN Terms

TermDefinition
Cast spreaderA hand-operated surgical instrument with specially designed blades used to separate and spread hardened plaster, i.e., that which has already been used to form a cast around a patient's limb or body part. It is designed like a large size forceps with flat serrated (serrated on the outer edge) blades that may be exchangeable and which are wedge-shaped (thin at the working end). These blades are prised between the cut plaster cast and pressure is exerted upon the handles by squeezing them together, forcing the plaster cast to separate. It is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags

DUNS number
081277700
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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