FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD9352080300
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD935208030
Catalog number
SD935208030
Device description
Freeman Areola Marker, 30mm
Published
2024-06-25
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
EILGAUGE, DEPTH, INSTRUMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EILGauge, Depth, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD9352080300PrimaryHIBCC0

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD134188100Surgical DirectSD13418-810SD13418-8102026-10-06
B382SD13798330Surgical DirectSD13798-33SD13798-332026-10-06
B382SD6520450Surgical DirectSD65-2045SD65-20452026-10-06
B382SD6562120Surgical DirectSD65-6212SD65-62122026-10-06
B382SD902866230Surgical DirectSD90286623SD902866232026-10-06
B382SD905582180Surgical DirectSD90558218SD905582182026-10-06
B382SD9056791090Surgical DirectSD905679109SD9056791092026-10-06
B382SD9056791170Surgical DirectSD905679117SD9056791172026-10-06
B382SD915598230Surgical DirectSD91559823SD915598232026-10-06
B382SD56534330Surgical DirectSD56534-33SD56534-332025-09-10
B382SD4830050Surgical DirectSD48-3005SD48-30052025-12-08
B382SD9141792000Surgical DirectSD914179200SD9141792002024-06-24
B382SD907186100Surgical DirectSD90718610SD907186102023-04-24
B382SD934496030Surgical DirectSD93449603SD934496032023-02-22
B382SD917665010Surgical DirectSD91766501SD917665012022-12-01
B382SD934496020Surgical DirectSD93449602SD934496022022-12-01
B382SD1618230Surgical DirectSD161823SD1618232022-11-23
B382SD161824530Surgical DirectSD16182453SD161824532022-11-23
B382SD413690Surgical DirectSD41369SD413692020-04-27
B382SD232590Surgical DirectSD23259SD232592020-04-25

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Primary DI, Brand, Company table
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00810213814840EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-19
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00810135961233ToejackNVision Biomedical Technologies, Inc.EIL2026-07-29
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G149TBSB4240TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4250TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4260TBS BASICSACME ENTERPRISE.EIL2026-05-20
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