FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD9028531550
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD902853155
Catalog number
SD902853155
Device description
"5 1/8"" Kelley Decemet Membrane Punch"
Published
2025-05-14
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
B382SD9028531550PrimaryHIBCC0

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
B382S8711000Surgical DirectS871.100S871.1002026-07-14
B382S8711010Surgical DirectS871.101S871.1012026-07-14
B382S8711020Surgical DirectS871.102S871.1022026-07-14
B382SD08890310101D0Surgical DirectSD08890-31010-1DSD08890-31010-1D2026-07-14
B382SD08890320101D0Surgical DirectSD08890-32010-1DSD08890-32010-1D2026-07-14
B382SD1184590Surgical DirectSD118459SD1184592026-07-14
B382SD123750Surgical DirectSD12375SD123752026-07-14
B382SD123760Surgical DirectSD12376SD123762026-07-14
B382SD123780Surgical DirectSD12378SD123782026-07-14
B382SD124326191140Surgical DirectSD12432-619-114SD12432-619-1142026-07-14
B382SD12711090Surgical DirectSD1271-109SD1271-1092026-07-14
B382SD1271390Surgical DirectSD1271-39SD1271-392026-07-14
B382SD1271590Surgical DirectSD1271-59SD1271-592026-07-14
B382SD13018770Surgical DirectSD13018-77SD13018-772026-07-14
B382SD13024290Surgical DirectSD1302.429SD1302.4292026-07-14
B382SD13168350Surgical DirectSD13168-35SD13168-352026-07-14
B382SD209910FSANT0Surgical DirectSD209910-FS-AN-TSD209910-FS-AN-T2026-07-14
B382SD209920FSANT0Surgical DirectSD209920-FS-AN-TSD209920-FS-AN-T2026-07-14
B382SD209923FSANT0Surgical DirectSD209923-FS-AN-TSD209923-FS-AN-T2026-07-14
B382SD2303290Surgical DirectSD230329SD2303292026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083275525Intrace USAPILOTIS TECH LLCEFL2026-07-03
05060212051264College Dental Forceps 160mmDTR MEDICAL LIMITEDEFL2026-06-10
B382S28531030Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382S28531040Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382S2853252T0Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382S285401100Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD902172106T0Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9023191000Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9027351020Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9028531080Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9028531260Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9028531290Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9028531720Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9028541100Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9028541170Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD902861100T0Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD902869400Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD902870110Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD902991101T0Surgical DirectSurgical Direct, Inc.EFL2026-06-08
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