FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD19300
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD1930
Catalog number
SD1930
Device description
Periotome Straight, Single Ended
Published
2026-07-31
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
EIXPROBE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIXProbe, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD19300PrimaryHIBCC0

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
false
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
B382SD488603LH0Surgical DirectSD48-8603LHSD48-8603LH2026-09-23
B382SD914763020Surgical DirectSD91476302SD914763022026-10-30
B382SD482036PH0Surgical DirectSD48-2036PHSD48-2036PH2026-10-13
B382SD05600Surgical DirectSD0560SD05602020-04-26
B382SD402590Surgical DirectSD40259SD402592026-11-03
B382SD429490Surgical DirectSD42949SD429492026-11-03
B382SD62031510Surgical DirectSD62-031-51SD62-031-512026-11-04
B382SD89259100Surgical DirectSD8925-910SD8925-9102026-11-03
B382SD89519020Surgical DirectSD8951-902SD8951-9022026-11-03
B382SD902171200Surgical DirectSD90217120SD902171202026-11-04
B382SD9146531600Surgical DirectSD914653160SD9146531602026-11-04
B382SD9146531620Surgical DirectSD914653162SD9146531622026-11-04
B382SD9146531630Surgical DirectSD914653163SD9146531632026-11-04
B382SD9146531640Surgical DirectSD914653164SD9146531642026-11-04
B382SD9152181060Surgical DirectSD915218106SD9152181062026-11-03
B382SD9152181070Surgical DirectSD915218107SD9152181072026-11-03
B382SD9180201110Surgical DirectSD918020111SD9180201112026-11-04
B382SD921171120Surgical DirectSD92117112SD921171122026-11-03
B382SD921171190Surgical DirectSD92117119SD921171192026-11-03
B382SD922864110Surgical DirectSD92286411SD922864112026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G8791021510DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791021511B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102151H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102157H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102158H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102159H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G87910217U150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791021NH0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G87910223C1150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G87910223GF0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791022NH0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791023AU150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791026QW0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CP02H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CP110DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CP1150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CPN100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CPN110DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CPN120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CPN150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102GFP0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102W11B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102WGF0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
08057639712677Needle tip - BLKMC BIO SRLEIX2026-07-28
08057639712684Needle tipMC BIO SRLEIX2026-07-28
00850083275693Intrace USAPILOTIS TECH LLCEIX2026-07-03
10856364008100Florida ProbeFlorida Probe CorporationEIX2023-08-08
B382SD934496030Surgical DirectSurgical Direct, Inc.EIX2023-02-22
07898506811861QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811878QuinelatoSchobell Industrial LtdaEIX2022-12-08