FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD914721100
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD91472110
Catalog number
SD91472110
Device description
"8 5/8"" Cloward Style Bone Graft Impactor"
Published
2023-07-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIGRetractor, All Types

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIGRetractor, All TypesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD914721100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical tamp, reusableA hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(386) 738-1202info@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
08961104622197Cheek Retractor SmallMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622203Cheek Retractor SmallMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622210Cheek RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622227Cheek RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622234Lip RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622241Cheek Retractor SmallMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622258Cheek Retractor SmallMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622265Cheek RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622272Cheek RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622289Lip RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
10304040196998Henry ScheinHENRY SCHEIN, INC.EIG2026-05-14
10304040197001Henry ScheinHENRY SCHEIN, INC.EIG2026-05-14
10304040197018Henry ScheinHENRY SCHEIN, INC.EIG2026-05-14
00348783010220Premier RetractorsPREMIER DENTAL PRODUCTS COMPANYEIG2026-05-06
G149NP260020NPSACME ENTERPRISE.EIG2026-05-01
G149NPORR0NPSACME ENTERPRISE.EIG2026-05-01
00371347023459Advance Dental ProductsThe Atlanta Dental Supply CompanyEIG2026-04-14
B382SD9144082080Surgical DirectSurgical Direct, Inc.EIG2026-02-12
B382SD9210921010Surgical DirectSurgical Direct, Inc.EIG2026-02-12
00841336128828Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIG2025-11-04
00190707191153Ortho Technology®Ortho Organizers, Inc.EIG2025-10-23
00190707191160Ortho Technology®Ortho Organizers, Inc.EIG2025-10-23
B382SD5615280Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640120Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640140Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640160Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640180Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640200Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640220Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640300Surgical DirectSurgical Direct, Inc.EIG2025-10-06