FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD913283200
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD91328320
Catalog number
SD91328320
Device description
3 1/4 inch Castroviejo Caliper, Curved
Published
2022-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTYTAPE, MEASURING, RULERS AND CALIPERS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD913283200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical ruler, reusableA small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be an independent bendable strip applied to measured surfaces or a strip incorporated into a form convenient for measuring specific devices (e.g., screws). It is not dedicated to wound measurements. This is a reusable device.

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
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
false
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
B382S1350010Surgical DirectS1350.01S1350.012026-03-09
B382S18382020Surgical DirectS1838.202S1838.2022026-03-09
B382S18382030Surgical DirectS1838.203S1838.2032026-03-09
B382S18382040Surgical DirectS1838.204S1838.2042026-03-09
B382S18382050Surgical DirectS1838.205S1838.2052026-03-09
B382S18382060Surgical DirectS1838.206S1838.2062026-03-09
B382S18382100Surgical DirectS1838.210S1838.2102026-03-09
B382S18382110Surgical DirectS1838.211S1838.2112026-03-09
B382S18382120Surgical DirectS1838.212S1838.2122026-03-09
B382S2511200Surgical DirectS2511.20S2511.202026-03-09
B382S2548010Surgical DirectS2548.01S2548.012026-03-09
B382S2548020Surgical DirectS2548.02S2548.022026-03-09
B382S2871200Surgical DirectS2871.20S2871.202026-03-09
B382S344901020Surgical DirectS34490.102S34490.1022026-03-09
B382S3797050Surgical DirectS3797.05S3797.052026-03-09
B382S9057001000Surgical DirectS905700.100S905700.1002026-03-09
B382SD18129DK0Surgical DirectSD18129DKSD18129DK2026-03-09
B382SD40060510052E00Surgical DirectSD40060-51005-2ESD40060-51005-2E2026-03-09
B382SD4387110Surgical DirectSD4387-11SD4387-112026-03-09
B382SD481753PTSTR0Surgical DirectSD48-1753PT-STRSD48-1753PT-STR2026-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118154255LEVEL ONE EXTREMITYKLS-Martin L.P.FTY2026-05-25
00810180843331Durma+ DynaRule Disposable Paper RulersDynarex CorporationFTY2026-03-24
08806373887703BENCOX Surgical InstrumentsCorentec Co., LtdFTY2026-02-23
00842071152963AMT Balloon Measuring DeviceAPPLIED MEDICAL TECHNOLOGY, INC.FTY2026-02-20
B382SD2644404000Surgical DirectSurgical Direct, Inc.FTY2026-02-16
00757770421848Bausch + LombBausch & Lomb IncorporatedFTY2026-02-11
03662663108072Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2026-02-11
03662663108089Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2026-02-11
B382SD91328410000Surgical DirectSurgical Direct, Inc.FTY2026-02-10
08681506801500SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIFTY2026-02-09
08681506801593ScharfSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIFTY2026-01-31
00847538005479Patella CaliperSYMMETRY MEDICAL INC.FTY2025-12-10
09348811038784INKAThe Trustee for KAISER FAMILY TRUSTFTY2025-12-02
00810207782599Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDFTY2025-11-24
00887868287503Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLCFTY2025-11-14
04719846016576CharderCHARDER ELECTRONIC CO., LTD.FTY2025-11-13
00763000684044Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.FTY2025-09-21
B382SD1327110040Surgical DirectSurgical Direct, Inc.FTY2025-09-09
04059453050144Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFTY2025-08-25
00757770405237Bausch + LombBausch & Lomb IncorporatedFTY2025-08-13
00757770413102Bausch + LombBausch & Lomb IncorporatedFTY2025-08-13
00757770450831Bausch + LombBausch & Lomb IncorporatedFTY2025-08-13
00757770676309Bausch + LombBausch & Lomb IncorporatedFTY2025-08-13
00757770413843Bausch + LombBausch & Lomb IncorporatedFTY2025-08-12
00757770422531Bausch + LombBausch & Lomb IncorporatedFTY2025-08-12
00757770669615Bausch + LombBausch & Lomb IncorporatedFTY2025-08-12
20197344154651MEDLINEMEDLINE INDUSTRIES, INC.FTY2025-07-28
00190776406899MillenniumAvalign Technologies, Inc.FTY2025-07-25
04059453186676Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFTY2025-07-23
B382SD1325910000Surgical DirectSurgical Direct, Inc.FTY2025-07-23