FDA.reportPublic FDA data

NA

Primary DI
07611819996076
Brand
NA
Company
Synthes GmbH
Model
532.027
Catalog number
532027
Device description
REPLACEMENT KEY FOR SAW ATTACHMENT 532.026
Published
2016-12-31
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819996076Direct MarkingGS10
10886982240682PrimaryGS10
H6795320270SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819996076076118199960767611819996076
1088698224068210886982240682

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill chuck keyA hand-held device designed to close and tighten the adjustable jaws of a surgical drill chuck onto a cutting tool, normally a drill bit or other rotational cutting tool, for a firm grip. It is inserted into any one of three side holes that are spaced around the inner barrel of the chuck, and will engage the geared portion of the outer barrel. When rotated, the key will turn the outer barrel, which in turn closes and locks the jaws of the chuck upon the cutting tool. To loosen, the reverse action is taken. It is typically made of high-grade stainless steel to resist the corrosive effects of sterilization processes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14
10705034754741VERTEBRAL SPACER-TR08.804.037088040372015-09-14
10705034754765VERTEBRAL SPACER-TR08.804.039088040392015-09-14
10705034754826VERTEBRAL SPACER-TR08.804.047088040472015-09-14
10705034762852ACIS08.843.805088438052015-09-14
10705034762876ACIS08.843.806088438062015-09-14
10705034762890ACIS08.843.807088438072015-09-14
10705034762913ACIS08.843.808088438082015-09-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613327652758N/ASTRYKER CORPORATIONHWE2026-03-25
07613327652789N/ASTRYKER CORPORATIONHWE2026-03-25
07640187462302Power Tool TL Attachment 2.5mmBonebridge AGHWE2025-10-17
07613327649161T2, PANGEAStryker GmbHHWE2025-09-25
07613327566000T2 ALPHAStryker GmbHHWE2024-03-01
07613327566055T2 ALPHAStryker GmbHHWE2024-03-01
07613327566079T2 ALPHAStryker GmbHHWE2024-03-01
07613327538939Prep PlusSTRYKER CORPORATIONHWE2023-01-04
07613327539332Mill PlusSTRYKER CORPORATIONHWE2023-01-04
07613327539349Mill PlusSTRYKER CORPORATIONHWE2023-01-04
07613327539448Mill PlusSTRYKER CORPORATIONHWE2023-01-04
07613327542134Bone Mill PlusSTRYKER CORPORATIONHWE2022-12-22
07613327467765EZoutSTRYKER CORPORATIONHWE2021-06-17
07613327467864PrecisionSTRYKER CORPORATIONHWE2021-06-17
07613327467819NASTRYKER CORPORATIONHWE2021-06-15
07613327467826NASTRYKER CORPORATIONHWE2021-06-15
07613327467833NASTRYKER CORPORATIONHWE2021-06-15
07613327467840NASTRYKER CORPORATIONHWE2021-06-15
07613327467857NASTRYKER CORPORATIONHWE2021-06-15
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08800038040373Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040380Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040397Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040403Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040410Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040427Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040441Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040458Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17