FDA.report

N/A

Primary DI
10381780044697
Brand
N/A
Company
NEWDEAL
Model
119651ND
Catalog number
119651ND
Device description
GENERAL INSTRUMENT Large Integra distraction Forceps 21cm Closed Arms
Published
2018-10-16
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
HTDFORCEPS

Product Code Classifications

CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780044697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178004469710381780044697

GMDN Terms

TermDefinition
Bone distraction forcepsA hand-held, manual, open-surgery instrument with sturdy handles and blade-like jaws designed to distract (force apart) two bone surfaces to enable a surgical procedure, e.g., two vertebrae during a spinal surgical intervention. It has a scissors-like lever action with straight or curved handles and is typically made of high-grade stainless steel. It is available in various sizes with the distraction blades at the working end which are activated through a single or double-jointed pivot that transfers the necessary force to create distraction; the blades are typically short and slender to fit between bone segments or pre-implanted pedicle screws. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

Regulatory Flags

DUNS number
536935331
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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10381780045892IPP-ON230001SND230001SND2017-10-09
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M248PANTAXLSET1PANTA XLPANTAXLSETPANTAXLSET2015-09-24
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10381780064381B-BOPBBOPSETBBOPSET2017-10-09
M248119580ND1I.CO.S®119580ND2017-05-26
M248119590ND1I.CO.S®119590ND2017-05-26
M248139107ND1METIS®139107ND2017-05-26
M248529061ND1SURFIX®529061ND2017-06-06
10381780043317BASAL DORSAL PLATE116010SND116010SND2017-10-09

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