FDA.reportPublic FDA data

NA

Primary DI
37613153089026
Brand
NA
Company
STRYKER CORPORATION
Model
0277082085S7
Catalog number
0277082085S7
Device description
Drill Bit 2.0mm (5/64'') x 128.0mm
Published
2018-09-23
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFGBIT, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFGBit, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613153089026PackageGS16In Commercial Distribution
07613153089025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761315308902637613153089026
07613153089025076131530890257613153089025

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, single-use, non-sterileA non-sterile shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, its shaft is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length128Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)253-3210Inst.Stryker.cs@Stryker.com

Regulatory Flags#

DUNS number
196548481
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
07613252450337ICONIX3910-500-5123910-500-5122015-08-26
07613252450344ICONIX3910-500-5223910-500-5222015-08-26
07613252450351ICONIX3910-500-5253910-500-5252015-08-26
07613252450368ICONIX3910-500-5323910-500-5322015-08-26
07613327176926ICONIX39105003123910-500-3122015-09-14
07613327176933ICONIX39105003223910-500-3222015-09-14
07613327283440ICONIX39105002123910-500-2122016-09-22
07613327298642Sonopet iQ55000083005500-008-3002019-05-03
07613327056952SERFAS Energy0279351100279-351-1002016-09-23
07613327056976SERFAS Energy0279351103279-351-1032016-09-23
07613327057027SERFAS Energy0279401100279-401-1002016-09-23
07613327057034SERFAS Energy02794012000279-401-2002016-09-23
07613327057041SERFAS Energy02793514000279-351-4002016-09-23
07613327058048CrossFlow045000000004500000002016-09-23
07613327294606NanoTackCAT02969CAT029692016-07-20
07613327643800NA79000620007900-062-0002025-12-19
07613327643824NA79001260007900-126-0002025-12-19
07613327643848NA79001250007900-125-0002025-12-19
00897146002025Adherus NUS-109NUS-1092016-12-19
00897146002018Adherus NUS-106NUS-1062015-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277326200MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277348813MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277354005MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277354012MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277354029MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277354074MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277354296MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277355057MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277378261MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277378278MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277387805MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277390676MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10080196393152MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277322295MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277329485MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277330054MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277334663MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277336971MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277337121MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277337183MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277353480MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277354180MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277354647MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277355132MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277355439MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277356023MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277356702MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277372269MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277374478MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277377196MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29