FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382S2853164T0
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
S2853.164T
Catalog number
S2853.164T
Device description
"3"" Utrata MICS Capsulorhexis Forceps, Angled 12mm from Bend to Tip, Extremely Thin Triangular Grasping Tips, Serrated Flat Handle, Titanium"
Published
2024-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFLFORCEPS, DRESSING, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFLForceps, Dressing, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382S2853164T0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dressing/utility forceps, scissors-like, reusableA hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 519-3293info@surgicaldirect.com

Regulatory Flags#

DUNS number
124367223
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD512531140Surgical DirectSD51253114SD512531142026-02-03
B382SD77321140Surgical DirectSD7732114SD77321142026-02-03
B382SD97321140Surgical DirectSD9732114SD97321142026-02-02
B382SD97321150Surgical DirectSD9732115SD97321152026-02-02
B382SD97331160Surgical DirectSD9733116SD97331162026-02-02
B382SD51531140Surgical DirectSD5153114SD51531142025-12-02
B382SD65331140Surgical DirectSD6533114SD65331142025-12-02
B382SD67511170Surgical DirectSD6751117SD67511172025-06-04
B382SD95321140Surgical DirectSD9532114SD95321142025-06-04
B382SD84531130Surgical DirectSD8453113SD84531132025-04-03
B382SD92422150Surgical DirectSD9242215SD92422152025-03-17
B382SD512531150Surgical DirectSD51253115SD512531152025-03-10
B382SD123200Surgical DirectSD12320SD123202024-12-12
B382SD52321110Surgical DirectSD5232111SD52321112024-08-08
B382SD82421110Surgical DirectSD8242111SD82421112024-08-01
B382SD81531140Surgical DirectSD8153114SD81531142024-03-12
B382SD82131160Surgical DirectSD8213116SD82131162024-03-12
B382SD42531170Surgical DirectSD4253117SD42531172024-02-23
B382SD4810450Surgical DirectSD481045SD4810452024-01-31
B382SD77311150Surgical DirectSD7731115SD77311152023-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB7960TBS BASICSACME ENTERPRISE.EFL2026-05-22
G149TBSB7970TBS BASICSACME ENTERPRISE.EFL2026-05-22
G149TBSB7980TBS BASICSACME ENTERPRISE.EFL2026-05-22
G149NP380750NPSACME ENTERPRISE.EFL2026-05-01
G149NPRMF0NPSACME ENTERPRISE.EFL2026-05-01
00371347023503Advance Dental ProductsThe Atlanta Dental Supply CompanyEFL2026-04-14
ESAM3851141STOMA®Storz am Mark GmbHEFL2026-03-25
B382S2511200Surgical DirectSurgical Direct, Inc.EFL2026-03-09
B382S2548010Surgical DirectSurgical Direct, Inc.EFL2026-03-09
B382S2548020Surgical DirectSurgical Direct, Inc.EFL2026-03-09
B382S2871200Surgical DirectSurgical Direct, Inc.EFL2026-03-09
B382SD9025111020Surgical DirectSurgical Direct, Inc.EFL2026-03-09
B382SD9027671000Surgical DirectSurgical Direct, Inc.EFL2026-03-09
B382SD9029931200Surgical DirectSurgical Direct, Inc.EFL2026-03-09
G1493807407TBS DentalACME ENTERPRISE.EFL2026-03-02
G1493807508TBS DentalACME ENTERPRISE.EFL2026-03-02
B382S8531000Surgical DirectSurgical Direct, Inc.EFL2026-02-12
B382SD6525000Surgical DirectSurgical Direct, Inc.EFL2026-02-12
B382SD9028701240Surgical DirectSurgical Direct, Inc.EFL2026-02-12
B382S349601020Surgical DirectSurgical Direct, Inc.EFL2026-02-10
B382SD902544180Surgical DirectSurgical Direct, Inc.EFL2026-02-04
B382SD9025471040Surgical DirectSurgical Direct, Inc.EFL2026-02-04
B382SD90260200Surgical DirectSurgical Direct, Inc.EFL2026-02-04
B382SD9028531460Surgical DirectSurgical Direct, Inc.EFL2026-02-04
B382SD9028532000Surgical DirectSurgical Direct, Inc.EFL2026-02-04
B382SD9028532510Surgical DirectSurgical Direct, Inc.EFL2026-02-04
B382SD9028541010Surgical DirectSurgical Direct, Inc.EFL2026-02-04
00841013120718Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06
00841013120725Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06
00841013120732Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06