FDA.reportPublic FDA data

Infinity™

Primary DI
10845854087558
Brand
Infinity™
Company
Conmed Corporation
Model
RDBH
Catalog number
RDBH
Device description
Infinity™ Reusable Double Blade Handle
Published
2026-06-10
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
NBHAccessories, arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20845854087555Direct MarkingGS10
10845854087558PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084585408755520845854087555
1084585408755810845854087558

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
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
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20845854042004Y-KNOTYH01YH012015-10-24
20845854042028Y-KNOTYH02YH022015-10-24
10845854087534Infinity™QTSLQTSL2026-06-10
10845854087541Infinity™QTSRQTSR2026-06-10
20653405990328Infinity™QTCRQTCR2026-06-10
20653405990366Infinity™ADB-0808ADB-08082026-06-10
20653405990373Infinity™ADB-0609ADB-06092026-06-10
20653405990380Infinity™ADB-0809ADB-08092026-06-10
20653405990397Infinity™ADB-0610ADB-06102026-06-10
20653405990403Infinity™ADB-0810ADB-08102026-06-10
20653405990410Infinity™ADB-0611ADB-06112026-06-10
20653405990427Infinity™DB-0808DB-08082026-06-10
20653405990434Infinity™DB-0609DB-06092026-06-10
20653405990441Infinity™DB-0809DB-08092026-06-10
20653405990458Infinity™DB-0610DB-06102026-06-10
20653405990465Infinity™DB-0810DB-08102026-06-10
20653405990472Infinity™DB-0611DB-06112026-06-10
10653405002765ABC® Bend-A-Beam®1340091340092016-09-24
10845854015506CONMEDC2630C26302015-12-10
10845854015865CONMEDC2632C26322015-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421694MillenniumAvalign Technologies, Inc.NBH2026-06-24
00198506091551ELMED INCORPORATEDELMED INCORPORATEDNBH2026-06-10
00198506091575ELMED INCORPORATEDELMED INCORPORATEDNBH2026-06-10
00857915007804STRATOS Endoscopic Release System (GEN 2) Case of 5A.M. SURGICAL, INC.NBH2026-06-10
20857915007815STRATOS Endo Release Kit (GEN 2) Case of 5A.M. SURGICAL, INC.NBH2026-06-10
00857915007705STRATOS (Gen2)A.M. SURGICAL, INC.NBH2026-06-05
00857915007033RetraBE Single - Gen 2 DepricatedA.M. SURGICAL, INC.NBH2026-06-04
00857915007781Retra Uni Gen 1 (5-Pack)A.M. SURGICAL, INC.NBH2026-06-04
00857915007798Retra Uni Gen 1 SingleA.M. SURGICAL, INC.NBH2026-06-04
10857915007030RETRA Single - GEN 2 DepricatedA.M. SURGICAL, INC.NBH2026-06-04
00857915007026Scope AdapterA.M. SURGICAL, INC.NBH2026-06-01
04059453163318Hermann Medizintechnik GmbHHermann Medizintechnik GmbHNBH2026-05-29
00857915007699Locking AttachmentA.M. SURGICAL, INC.NBH2026-05-20
07630345721204Surgical Manual InstrumentMedacta International SANBH2026-03-30
07630345721211Surgical Manual InstrumentMedacta International SANBH2026-03-30
07630345721228Surgical Manual InstrumentMedacta International SANBH2026-03-30
10080196385386MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196385478MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196392032MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196392070MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196392292MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196385218MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-01-29
10845854026946DOUBLELATCHConmed CorporationNBH2023-12-05
10080196387984MedlineMEDLINE INDUSTRIES, INC.NBH2023-10-09
B382SD48820700Surgical DirectSurgical Direct, Inc.NBH2023-05-24
07630345778765Sports Med InstrumentsMedacta International SANBH2023-01-16
07630542702457Sports Med InstrumentsMedacta International SANBH2023-01-16
07613327379624NASTRYKER CORPORATIONNBH2022-12-06
B382SD48820070Surgical DirectSurgical Direct, Inc.NBH2022-12-02
B382SD48820080Surgical DirectSurgical Direct, Inc.NBH2022-12-02