FDA.reportPublic FDA data

Stryker

Primary DI
B504CBEN60000
Brand
Stryker
Company
Provision
Model
EN6000
Published
2024-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, ReprocessedGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172647000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172647000Reprocessed ArthroCare ENT CoblatorRenovo, Inc.2018-02-21NUJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B504CBEN60000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessedA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery; it may in addition be intended for open surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a previously used single-use device that has been processed for an additional single-use patient application.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature7 Degrees Celsius32 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
541-422-8880mark@provisiondrs.com

Regulatory Flags#

DUNS number
016889401
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B504OMBMAS90006S0BrasselerBMA-S90006S2026-10-20
B504OMBMAS90007S0BrasselerBMA-S90007S2026-10-20
B504OMBMAS90008S0BrasselerBMA-S90008S2026-10-20
B504OMBMLS900040BrasselerBML-S900042026-10-20
B504OMBR2544001110BrasselerBR2544-00-1112026-10-20
B504OMBR9505023020BrasselerBR9505-02-3022026-10-20
B504OMBR9505023030BrasselerBR9505-02-3032026-10-20
B504OMDP86011710BrasselerDP86-0117-12026-10-20
B504OMST60070031000BrasselerST6007-003-1002026-10-20
B504OMST60070031500BrasselerST6007-003-1502026-10-20
B504OMST60071031100BrasselerST6007-103-1102026-10-20
B504OMST60071041500BrasselerST6007-104-1502026-10-20
B504OMZB005901020000BrasselerZB00-5901-020-002026-10-20
B504GS80200Vericel80202026-07-20
B504GS80210Vericel80212026-07-20
B504GS80220Vericel80222026-07-20
B504OM19S17050Brasseler19-S17052026-07-20
B504OM22963414S70Stryker2296-3-414S72026-07-20
B504OM3162880Synthes316.2882026-07-20
B504OM4058830Biomet4058832026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327666878N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NUJ2026-06-25
07613327666885N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NUJ2026-06-25
07613327666892N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NUJ2026-06-25
07613327666908N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NUJ2026-06-25
07613327666915N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NUJ2026-06-25
07613327666922N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.NUJ2026-06-25
00850044399000NES Reprocessed Varicose Vein RF CatheterNORTH EAST SCIENTIFIC INCNUJ2025-05-21
00850044399017NES Reprocessed Varicose Vein RF CatheterNORTH EAST SCIENTIFIC INCNUJ2025-05-21
00850044399024NES Reprocessed Varicose Vein RF CatheterNORTH EAST SCIENTIFIC INCNUJ2025-05-21
00850044399031NES Reprocessed RF Stylet (RFS)NORTH EAST SCIENTIFIC INCNUJ2025-05-21
10888277408746MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-02-14
20888277408743MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-02-14
10888277408739MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-30
20888277408736MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-30
10888277325227MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277391987MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277414907MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680326MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680333MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680340MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680357MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680371MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680395MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680432MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277719330MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277719354MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277719378MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277719392MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
B504AEAR98310ArthrexProvisionNUJ2024-09-17
B504CB1381050ConMedProvisionNUJ2024-07-01