FDA.reportPublic FDA data

NA

Primary DI
04546540859495
Brand
NA
Company
STRYKER CORPORATION
Model
0206725000
Catalog number
0206725000
Device description
Stainless Steel Inserter
Published
2018-09-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDYGAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540859495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540859495045465408594954546540859495

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement preparation/delivery kitA collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.

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
true
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
07613327687637N/A65170400166517-040-0162026-03-19
07613327687644N/A65170400106517-040-0102026-03-19
07613327687651N/A65170700216517-070-0212026-03-19
07613327687668N/A65170480216517-048-0212026-03-19
07613327687675N/A65170400126517-040-0122026-03-19
07613327628357RPS88080000008808-000-0002025-10-01
07613327656763BPX79000120007900-012-0002026-03-04
07613327656770BPX79000130007900-013-0002026-03-04
07613327657760BPX79000340007900-034-0002026-03-04
07613327657777BPX79000150007900-015-0002026-03-04
07613327657784BPX79000310007900-031-0002026-03-04
07613327657791BPX79000990007900-099-0002026-03-04
07613327657807N/A79003760107900-376-0102026-03-04
07613327657814BPX79000370007900-037-0002026-03-04
07613327657821N/A79003770107900-377-0102026-03-04
07613327657838N/A79003780107900-378-0102026-03-04
07613327659429BPX79000250007900-025-0002026-03-04
37613327693288Malis6760-180-0106760-180-010-Z012026-02-25
37613327693295Malis6760-180-0056760-180-005-Z012026-02-25
37613327693363Malis6760-180-0156760-180-015-Z012026-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50192253050293VistecCardinal Health 200, LLCGDY2026-03-05
10815555025678CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025685CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025661CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025630CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025623CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025647CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025654CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
50198956239690CARDINAL HEALTHCardinal Health 200, LLCGDY2025-11-28
10850049994863Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994870Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994887Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994894Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994900Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994917Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994924Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994931Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994948Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994955Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994962Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994979SynterventionZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994993Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-23
10850049994986Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-22
37613327465854SurgiCount Safety-SpongeSTRYKER CORPORATIONGDY2025-09-03
06979032640079GOBENHUZHOU JUNDA INDUSTRY CO., LTD.GDY2025-08-26
30193489015991MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-12
40888277338914MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-06
40193489079747MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-06
40193489079754MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-06
40193489079822MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-06