FDA.report

NA

Primary DI
07332747175776
Brand
NA
Company
Nobel Biocare AB
Model
37881
Catalog number
37881
Device description
Abutment Retrieval Instr Ti CC RP/WP
Published
2022-07-22
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
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07332747175776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07332747175776073327471757767332747175776

GMDN Terms

TermDefinition
Screw extractor, reusableA hand-held manual surgical tool designed to remove implanted screws that have a damaged screw recess by self-tapping into the defective recess/head and providing sufficient grip to rotate and remove the screw in the normal way. It typically has a conical tip. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight. Keep dry
Special Storage Condition, Specify00Keep away from sunlight.Keep dry

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)322-5001us.customerservice@nobelbiocare.com

Regulatory Flags

DUNS number
353939929
Device count
1
DM exempt
true
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
false
Sterilization required before use
true

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07332747225549NobelActive®3025653025652026-03-02
07332747225556NobelActive®3025663025662026-03-02
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07332747225570NA3025683025682026-03-02
07332747225587NA3025693025692026-03-02
07332747225594NA3025703025702026-03-02
07332747225839NobelActive®3025833025832026-03-02
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07332747221954NobelActive® S TiUltra™3022743022742026-02-26
07332747221961NobelActive® S TiUltra™3022753022752026-02-26
07332747221978NobelActive® S TiUltra™3022763022762026-02-26
07332747221985NobelActive® S TiUltra™3022773022772026-02-26
07332747221992NobelActive® S TiUltra™3022783022782026-02-26
07332747222005NobelActive® S TiUltra™3022793022792026-02-26
07332747222012NobelActive® S TiUltra™3022803022802026-02-26
07332747222029NobelActive® S TiUltra™3022813022812026-02-26
07332747222036NobelActive® S TiUltra™3022823022822026-02-26
07332747222043NobelActive® S TiUltra™3022833022832026-02-26
07332747222050NobelActive® S TiUltra™3022843022842026-02-26
07332747222067NobelActive® S TiUltra™3022853022852026-02-26

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